Global Regulatory Support

Credevo is a globally connected organization providing its expertise to pharma industries regardless of size and sector in all aspects of regulatory affairs

Our services

Our services extend from advice to full-range support, product registration service – right from dossier preparation and compilation to submissions with regulators worldwide, providing knowledge based advice for the best and most efficient regulatory pathway selection.

Marketing authorization of medicinal products

The final goal of any pharmaceutical organization is to place the drug into the market at the earliest and the pathway to get a product onto the market can be challenging.

Credevo has well-established infrastructure and expertise to provide regulatory support globally for marketing authorizations and life cycle management (LCM) of various pharmaceutical products, generic drugs, nutraceuticals, medical devices and Biosimilars.

Learn more on Generics & Biosimilars Market Trend & Regulatory

Credevo offers special services in rare disease drug registration with a complete understanding of various benefits and incentives provided by the regulators in the united states, Europe, Japan, Australia and in Asian countries

Learn more on Registration & FDA Support For Orphan Drugs in Rare Diseases

Learn more on various benefits and incentives provided by regulators in the United States, Europe, Japan, Australia, and Asian countries like India, China, South Korea, and Russia

Nutraceutical and Complementary medicines regulatory

Regulatory for medicinal products or pharmaceuticals is different from neutraceuticals or complementary medicines. Various regulators have predefined regulatory for marketing approval

Credevo has its expertise in getting approvals with various regulators around the world with sound knowledge of requirement and pathways to provide efficient and fast approvals

Learn more on how to Register Nutraceutical, Dietary Or Food Supplement Products In Europe

Learn more about the process for Regulatory Approval for Complementary Medicines in Australia

Rare Disease Services

Rare disease drug development is often challenging right from discovery to market approval as these drugs or medical devices are to be used by very few patients.

Credevo offers expertise in understanding the regulatory process and benefits provided by regulators and reduces the burden on the rare disease drug developers

Learn more on rare disease services provided on Credevo

Clinical trial applications

The clinical trial application process can be complex and can cost your organization significant time and money along with sound regulatory understanding 

Credevo provides expertise for all aspects of Clinical Trial Applications (CTA) and Investigational New Drug (IND) applications with sound knowledge and experience in working clinical regulators around the world

To learn more on the Clinical Trial Application (CTA) approval process & Regulatory in various regions click on the country below

Medical device regulatory

Rapid regulatory amendments are one of the most troublesome challenges for medical device companies in seeking approval of a new product. Another complication in medical devices is the regulations differ with several categories of medical devices

Credevo understands every regulatory requirement in-depth to provide flawless approval to medicals devices with good in-depth understating of various regulatory approaches. Credevo also processes special approvals such as Device 510(k), CE marking, etc.

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    Clinical Development Strategy | Clinical Trial Feasibility | Rare Disease Services | Global Clinical Operations